Did an Audiotape Squirrel Away the Minutes?

“Are you sure he said squirrels?” questioned Pat Woods, the IACUC
Administrator at Great Eastern University. Al Russo, the Committee
Chairman, nodded his head and assured Woods that a group of
researchers from the Department of Zoology wanted to do field and
laboratory research with ground squirrels. Woods smiled weakly
because she knew there would be considerable IACUC discussion about
this study.

At the IACUC meeting, it became apparent that Woods was right.
The discussion meandered through almost every conceivable nuance of
the protocol. In addition to many basic scientific questions, the
IACUC discussed housing, dietary needs, and related topics. Woods
was furiously writing as an audiotape recorded the discussion. After
nearly 45 minutes, the IACUC voted to approve the protocol pending
the Principal Investigator’s agreement to several
modifications.A few months later, with the ground squirrel study
in full swing, the USDA Veterinary Medical Officer (VMO) came to
Great Eastern for his annual inspection. Of course, he noticed the
ground squirrels, and because of their uniqueness as a laboratory
animal, asked to see the IACUC protocol and the minutes of the
associated meeting. Woods had duly noted in the minutes that the
IACUC discussed how the animals would be captured, whether
appropriate permits were needed, how they would be housed, and
whether there were biosafety concerns from enzootic diseases. There
also were questions concerning blood sampling in the field and
laboratory, euthanasia techniques, and so on. Nevertheless, the
minutes did not give much detail. They were largely in
single-sentence, outline format, just listing the questions raised
by the IACUC. The VMO seemed perturbed, and asked if there was any
other written information about the discussion that occurred at the
meeting. Woods then told him about the audiotape. The VMO responded
that he was looking for appended written information, otherwise it
could not be considered part of the meeting’s minutes.

Great Eastern was cited for not keeping adequate minutes of a
meeting. The VMO said that the sketchy statements in the existing
minutes did not allow him to discern the essence of the IACUC’s
deliberations. He pointed to other protocols discussed by the
Committee, and noted that they went into much more detail than did
the ground squirrel study. When Russo was called into the meeting
with the VMO, he strongly objected to the VMO’s position, arguing
that although the discussion on the ground squirrels had been long
and complicated, the minutes accurately reflected the main areas of
concern expressed by the IACUC. He said that just because there was
more detail provided about other studies, it did not mean that the
minutes reflecting the ground squirrel study were inadequate. He
felt that any reasonable person could understand the concerns of the
IACUC, and he knew of nothing that required the minutes to provide
more detail than that.

Do you agree with Russo or the VMO? Were Woods’ minutes adequate,
or is it necessary for IACUC minutes to provide more
information?

Minute Detail

Stephen Curtis, DVM, DACLAM

Creating adequate minutes is a troublesome question for many
institutions. The Association for Assessment and Accreditation
of Laboratory Animal Care (AAALAC) recognizes that the topic of
IACUC minutes is “one area in particular that continues to draw
questions from AAALAC constituents1.” Unfortunately, the Animal
Welfare regulations (AWR) lack specificity on this topic. AWR Sec.
2.35, Record Keeping Requirements, states that “the research
facility shall maintain… minutes of the IACUC meetings, including
records of attendance, activities of the Committee, and Committee
deliberations [and] records of proposed activities involving
animals, and whether IACUC approval was given or withheld…”
(emphasis added). There is similar language in the Public Health
Service Policy (Sec. IV.E). Lacking explicit guidance, it is not
surprising that the facility has cause to disagree with the VMO
citation.

Consistency may be the real problem in this case. It appears that
minutes covering some protocols provided more details than others
did. This drew undue attention to the squirrel protocol and gave the
VMO the impression that there was something to hide or that
something had been overlooked. Meeting recorders should be careful
that fatigue or boredom does not result in a reduced effort when
discussions are long or occur at the end of a long meeting. During
lengthy discussions, it may be hard to keep up with vigorous
exchanges, which may tempt the recorder to summarize without
completely capturing the essence of the discussion. Recorders should
not be timid in asking members to speak in turn, or in asking for a
restatement or clarification of what was said. Recorders may also
read back minutes to assure proper content.

In my opinion, and that of a standard dictionary, minutes are
only a brief summary of the activities of a Committee. Therefore,
the VMO may have failed to give proper attention to supporting
documents. I believe the minutes can reference other important
documents and documents that helped to bring the Committee to a
particular decision. For instance, many Committees designate
reviewers for all or selected protocols. These reviewers should be
asked to provide written notes, which can be referenced in the
minutes and added to the protocol file for future reference. The
tape recording of the meeting could be referenced, but in doing so,
the tape would have to be archived and saved in accordance with
regulations.

Since the tape was still available, the VMO erred in not
considering its content. The IACUC Chair might have avoided argument
if he had offered to provide a transcribed copy of the
squirrel-related section. In fact, if the specific citation is to be
corrected, the University may need to submit a more detailed record
based on the recording.

The Chair may also have overreacted. It is unclear who requested
his involvement, the VMO or the University. Where regulations fail
to provide clear guidance, it is sometime better to politely listen
to the VMO, engage in civil discussion, and accept the outcome
without undue stress or concern. It is unlikely that argument will
change the mind of an inflexible VMO; quite the contrary, “a soft
answer turneth away wrath, but grievous words stir up anger”
(Proverbs 15:1). In many cases, “confession and repentance” will
turn a citation into mere words of admonition.

The opinions expressed are solely those of the author and not of
the Veterans Administration or federal government. Curtis is Chief
Veterinary Medical Officer, VA Greater Los Angeles Healthcare
System, Veterinary Medical Unit, Sepulveda, CA.

Take a Minute to Update the Minutes

David L. Carlton, LATG, and Stacy Gillenwater, LAT

If the IACUC had the 45-minute discussion on tape, the tape
obviously should have been reviewed, and the minutes updated with
all the concerns brought up in the meeting. Everyone involved
realized that the use of squirrels would bring up many concerns.
Therefore, why should those concerns not have been addressed in the
minutes? When keeping records, we must be careful about keeping
sketchy, broad outline statements that don’t give specific details
about procedures. A one-sentence outline format listing only the
questions posed by the IACUC is not acceptable. Clearly, there was
information on the tape that was not reported in the minutes. In
this case, our vote is for the VMO.

NOTE: Tapes used to record meetings can also be considered a
record. According to The Freedom of Information Act, 5 USC §552, as
amended by Public Law No. 104-231, 110 Stat. 3048, “record” and any
other term used in this section in reference to information includes
any information that would be an agency record subject to the
requirements of this section when maintained by an agency in any
format, including an electronic format.

One of the main purposes of the IACUC is to act as a mediator
between the Institution and the USDA. During the annual inspections,
the VMO acts a representative of the USDA. One of the many ways the
VMO monitors the actions of the IACUC and assures the Institution’s
compliance with the Animal Welfare Act is by reviewing the written
minutes of IACUC meetings. As the VMO is not present at the meeting,
the only way to effectively communicate the issues addressed at the
IACUC meeting is to provide detailed written minutes for the VMO to
review at the annual inspection.

In this case, the audiotape of the IACUC meeting was in a format
that was not readily accessible to the VMO. As a result, the
information cannot be considered an appropriate record of the
minutes. Proper documentation of detailed minutes is the only way to
assure that the IACUC approval was adequate and that all the
concerns of the IACUC members were addressed. Russo’s comments, that
the ground squirrel discussion was “long and complicated,” should
raise a red flag to the VMO that something may be missing from the
written minutes. There is particular concern here due to the complex
nature of the ground squirrel protocol. Considering that this is a
unique and complicated protocol, it is important for the written
minutes of the meeting to provide extensive details of the
discussion and comments from the IACUC members. The VMO is correct
in thinking that the minutes were inadequate, particularly if his
questions and concerns about this species were not addressed in the
written minutes he reviewed. The Institution could have avoided the
citation by providing a written transcript of the audiotape for the
VMO to review.

A Word From OLAW and USDA

In response to the question posed in this scenario, the
Office of Laboratory Animal Welfare (OLAW) and United States
Department of Agriculture (USDA) offer the following
clarification and guidance:

The wording related to IACUC minutes, as found in Section
2.35(a) of the Animal Welfare Act regulations and paragraph IV
E of the Public Health Service Policy is identical;
specifically, research facilities are required to maintain
“minutes of IACUC meetings, including records of attendance,
activities of the Committee, and Committee deliberations.” We
have interpreted this requirement for a record of Committee
deliberations to mean that minutes will include an explanation
of the major issues discussed by the IACUC and the outcome of
the discussions for each issue. A written transcript of the
proceedings is clearly not required or even desirable from the
perspective of the federal oversight authorities; rather,
there should be enough information for an outsider to
ascertain the nature of the discussion and the conclusions
reached by the Committee.

The above scenario, as written, does not provide sufficient
information to judge whether the degree of detail in the
minutes is acceptable. In some cases, it may be obvious what
the outcome of a particular deliberation was. For example, the
protocol review form may reflect Committee acceptance of the
investigator’s proposal to use a specific anesthesia as
written. The results of deliberations may also be reflected in
IACUC-required modifications to the protocol, which would also
show up in the protocol review form and in correspondence with
the investigator.

On the other hand, if the deliberations involved
substantive issues not covered in the proposal or documented
in Committee action, some indication of the Committee’s
decisions or actions must be included in the minutes.

For the protocol in question at Great Eastern, it would
appear that the minutes listed the questions or issues raised
in the Committee deliberations. We are left to guess whether
or not the outcome of the actual deliberations was obvious or
documented in some other easily demonstrated way. While the
audiotape was offered as a well-intended adjunct to the
minutes, it is not an acceptable alternative to complete
easily reviewable minutes.

Additional records (in this case, the audiotape) that are
referenced in the IACUC minutes can be quite helpful when more
detail is needed, but such records cannot substitute for the
actual minutes that contain a record of the “Committee
deliberations.” This ability to reference the discussion can
be an important tool for Committees, administrators,
investigators, and Institutional Officials. Issues that arise
during the course of a study, semiannual inspection, or
protocol review can often be easily resolved with a reference
to the prior discussion.

From a practical standpoint, it is simply not feasible for
an IACUC, an inspector, or a site visitor to search through
(potentially) several hours of audiotape to glean the
information that should be readily available in summary format
in the minutes. Indeed, if audiotapes were acceptable, some
institutions might choose to use them in lieu of adequate
minutes, thus leaving inspectors and IACUCs with no choice but
to listen to hours of tape in order to determine the adequacy
or content of Committee deliberations and activities.